Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

This study has been completed.

Sponsor:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01329263

First Posted: April 5, 2011

Last Update Posted: January 6, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.

Further study details as provided by Andrew Strasser, University of Pennsylvania:

Primary Outcome Measures:

Smoking Topography- Puff Volume [ Time Frame: over 35 day study period ]

The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.

Smoking Topography- Carbon Monoxide Boost [ Time Frame: Measured before and after each cigarette smoked at study sessions ]

Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.

Nicotine Levels [ Time Frame: 35 days ]

Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.

Subjective Rating of Cigarettes [ Time Frame: Immediately after a cigarette smoked at the study session ]

Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.

This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

21 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Self-report smoking daily cigarettes

Self-report smoking menthol flavored cigarettes

Not currently trying to quit or planning to quit in the next 2 months.

Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette

Self-report smoking only filtered commercially made cigarettes

Exclusion Criteria:

Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week

Self report using any nicotine replacement products or nicotine-containing products other than cigarettes

Self-report substance use disorders in the last 5 years

Self-report current Axis I psychiatric disorders

Self-report past history of Axis I psychiatric disorders other than depression